Project Engineering Document Controller

Project Engineering Document Controller, Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  Hybrid 3 days per week on site. 

Pay: €40 - €45 per hour

Experience: 4+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

The role is responsible for assisting with the Engineering elements of the expansion project through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.

As a member of the Engineering team, support the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.

Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure requirements are in line with Amgen standards and fit for purpose.

This role is more focused on documentation and coordination, aimed at supporting the execution of engineering activities.

• Act as primary point of contact for vendor communications; coordinate meetings and manage vendor requests.

• Manage equipment and automation change controls task required

• Develop and maintain SOPs, supporting documents, and training materials for equipment setup and operation.

• Configure and maintain preventive maintenance plans, job plans, and job aids in Maximo.

• Establish spare parts systems in Maximo and collaborate with engineering stores.

• Create and manage recipe documentation, including parameter control and classification, and support recipe development and approval processes.

• Provide ongoing support to system owners with equipment-related activities as needed.

• Develop and maintain a centralised online system for vendor turnover packages.

• Maintain and enhance the engineering task dashboard for improved visibility and efficiency.

Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.

Good GMP skills, project skills from that focus of this stage of a project from initial setup to handover.

Used to dealing with quality and automation and PD from a change control and completing tasks that way. 

Requirements

Minimum of a Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical) with typically 4+ years of experience in engineering projects and systems.

Fundamental knowledge of applicable quality management and regulatory requirements.

Solid leadership, technical writing, and communication/presentation skills.

Experience in change control, non-conformance, corrective and preventative actions, and validation practices.

Experience in developing strategies for new product introduction and new technology deployment.

Team player who actively promotes a culture of clear communication, collaboration, and engagement at all relevant levels for effective decision-making.

Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.

Strong technical ability to understand and resolve complex problems as part of a focused and high-performing team.

Experience in vendor management and contract negotiations with a focus on equipment suppliers.

Independent, self-motivated, organized, and able to multi-task in project environments.

Package

Contract role - Hourly rate €40 - €45 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite expectations: Three days onsite, two days offsite. 

We will need the person to be onsite five days a week from March till the equipment is validated and tested.